QUEST FOR LOWER PRICES
While the FDA reviews drug-development data, it doesn’t fund
drug research. That’s on the pharmaceutical companies’ dime.
The FDA also “has no role in how drugs are priced,” says
Woodcock. She invokes former FDA Commissioner Mark
McClellan’s concerns about affordability.
“That was back in 2004,” she recalls. “I wrote a report in which
I discussed what we could do in FDA-regulated phases to make
drug trials and development programs more efficient and effective.
We’ve done a huge amount with public-private partnerships to
simplify trials, and we’re still working on that.” She’s also counting
on innovations such as electronic health records. “We can help
reduce the time needed for trials,” she says. “I believe we can lower
the cost of developing drugs through some of these measures.”
One of Woodcock’s top challenges in drug development and
regulation is figuring out why some people experience adverse
reactions to new drugs and others don’t. Sequencing the human
genome has brought about tissue typing to detect if someone has
a rare allele that could react adversely to a drug. “We’re trying to
understand the biological basis of different human responses to
drugs,” Woodcock says.
During her 30 years with the FDA, Woodcock has worked
under several presidential administrations. While presidents
may express interest in certain topics — for Obama, it’s been the
epidemic in prescription opioid abuse, she says — the FDA has
been largely immune to the political winds. “The fundamental
work is very scientific, and we like to keep it that way,” Woodcock
says. “We’re more successful the more we keep it strictly based on
policy and the science that we have.”
Woodcock came to the FDA in 1986 as a part-time drug reviewer.
A rheumatologist and new mom, she’d been on the faculty at
the University of California, San Francisco doing research in
rheumatology when her husband got a job at the National Institutes
of Health in Bethesda, Md.
“I was hired by a biologic center, because I had experience
doing research on monoclonal antibodies, which were very
experimental,” she explains. Because this was the height of the
AIDS epidemic and she was helping to regulate a therapeutic
vaccine, “I got thrown into media things right away. ‘Oh, you
can do 60 Minutes.’
“Pretty soon I was supervising the whole IND [Investigational
New Drugs] Division at CDER, and then I was deputy director,”
she says. She’s been CDER director since 1994, except for a few
years when she served as the FDA’s deputy commissioner and
chief medical officer.
When asked how she manages to lead an operation of 5,000
people, she says, “I’ve always been looked to as a leader. At
Bucknell, they made me captain of the cheerleaders. I was terrible
at it, but I’ve always been somebody that people look to and ask,
‘What’s the next step?’ ”